Loratadine by Fred's Inc. / Ranbaxy Pharmaceuticals Inc. / Ohm Laboratories Inc. LORATADINE tablet

Loratadine by

Drug Labeling and Warnings

Loratadine by is a Otc medication manufactured, distributed, or labeled by Fred's Inc., Ranbaxy Pharmaceuticals Inc., Ohm Laboratories Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT (IN EACH TABLET)

Loratadine USP, 10 mg

PURPOSE

Antihistamine

USES

Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

• runny nose
• itchy, watery eyes
• sneezing
• itching of the nose or throat

WARNINGS

Do not use

If you have ever had an allergic reaction to this product or any of its ingredients.

Ask a doctor before use if you have

Liver or kidney disease. Your doctor should determine if you need a different dose.

When using this product

Do not take more than directed. Taking more than directed may cause drowsiness.

Stop use and ask a doctor if

An allergic reaction to this product occurs. Seek medical help right away.

If pregnant or breast-feeding

Ask a health professional before use.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away.

DIRECTIONS

• adults and children 6 years and over: 1 tablet daily; not more than 1 tablet in 24 hours
• children under 6 years of age: ask a doctor
• consumers with liver or kidney disease: ask a doctor

OTHER INFORMATION

• store between 20 and 25° C (68 and 77° F)
• protect from excessive moisture
• TAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING.

INACTIVE INGREDIENTS

Corn starch, lactose monohydrate, magnesium stearate, pregelatinized starch

QUESTIONS?

Call 1-800-406-7984

PRINCIPAL DISPLAY PANEL

fred's®

Non-Drowsy*

* When taken as directed.

See Drug Facts Panel.

24 Hour

Allergy Relief

Loratadine Tablets USP, 10 mg

Antihistamine

INDOOR & OUTDOOR ALLERGIES

Relief of:

• Sneezing
• Runny Nose
• Itchy, Watery Eyes
• Itchy Throat and Nose

10 TABLETS

Compare to Active Ingredient of Claritin®†

INGREDIENTS AND APPEARANCE

LORATADINE 
loratadine tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55315-528
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LORATADINE (UNII: 7AJO3BO7QN) (LORATADINE - UNII:7AJO3BO7QN)	LORATADINE	10 mg

Inactive Ingredients
Ingredient Name	Strength
STARCH, CORN (UNII: O8232NY3SJ)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)

Product Characteristics
Color	white (White to Off-White)	Score	no score
Shape	ROUND	Size	6mm
Flavor		Imprint Code	RX526
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55315-528-69	10 in 1 BLISTER PACK; Type 0: Not a Combination Product	08/19/2003
2	NDC: 55315-528-31	30 in 1 BLISTER PACK; Type 0: Not a Combination Product	08/19/2003

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA076134	08/19/2003

Labeler - Fred's Inc. (005866116)

Registrant - Sun Pharmaceutical Industries Inc. (146974886)

Establishment
Name	Address	ID/FEI	Business Operations
Ohm Laboratories Inc.		051565745	manufacture(55315-528)